Job Purpose: To contribute to the success of our customers by ensuring first pass quality of Finished Goods through thorough, accurate, and timely audits of production lines, production processes and inspections of packaging materials and finished goods.
Job Duties and Responsibilities: (Percentages = priority and approximate time focus)
2. | Audits production lines for conformance to requirements in the Batch Record, product specifications, and cGMP requirements. 45% |
| · Performs audits on time, with a sharp focus on details. |
| · Accurately records audit results in Batch Records. |
| · Initiates corrective adjustments to manufacturing processes; records adjustments; performs documented rechecks to verify successful adjustment. |
| · Escalates issues per established procedures to ensure correction and containment. |
| · Initiates non-conformance reports and supports investigations of quality events, as required to resolve issues. |
| · Complies at all times with Standard Work, cGMP, SOPs, and Work Instructions. |
3. | Understand and maintain a culture of "lean action" within the department so that we live Lean better than any organization. 5% |
| · Implement and maintain standards and processes that eliminate waste throughout the department. |
| · Apply and utilize "lean tools" to permanently implement improvements. |
| · Institutionalize 5-S in all aspects of the department. (Sort, Straighten, Shine, Standardize, and Sustain) |
4. | Perform other work as assigned. 5% |
Direction and oversight: None.
Qualification and Skill Requirements:
Prior Experience:
Prior audit experience preferred.
Knowledge Requirements:
This position requires a high school diploma or equivalent. To be effective, this position requires the ability to multi-task, demonstrate a sense of urgency, and the ability to organize. 2- 3 years quality experience in a manufacturing environment preferred.
Licenses and Certifications: None
Certifications or required class attendance: None
Work Requirement:
This position may require significant work hours beyond the normal workday based on the demands of the business cycle, customer volume of business, and specific sales efforts underway. It has a moderate to high demand for tight deadlines. This position entails work of a cyclical nature. This position will experience moderate interruption in workflow, starting and stopping for production and customer requirements. Travel is limited.
Physical Requirements:
This position requires:
Working Conditions:
Work Schedule:
This position usually works for 8 hours during a shift. However, hours of work are flexible and will fluctuate based on the needs of the business and the customers. The job may require a maximum of 5 hours of work beyond the normal 40 work-week schedule depending on work demands. The work hours can vary depending on customer requirements and staffing.
Technical Competencies:
Core Purpose: To contribute to the success of our customers by helping them grow and save money.
Vision: Become the most respected, most admired, most sought after CPG contract manufacturer in the World.
Vivid Description: With our intimate knowledge of our customers we will provide products and services so valuable that we are considered an integral member of their team that they cannot live without. We will collaborate in a way that creates a tremendous competitive advantage to our customers. This competitive advantage comes from providing innovative products to the market faster than anyone, at the greatest value to the customer, and with quality that exceeds the consumer's expectations. Great customers seek us out. Our halls are filled with awards and testimonials bestowed upon us by our customers and suppliers. Our culture and environment attract the most passionate, committed, and highest achieving people in our industry. Our employees live our core values. We are proud of our accomplishments but are never satisfied with the status quo. We continuously improve in everyway, everyday.
Core Values
Customer Focused – Our success is based on customer intimacy-understanding the unique needs of each customer and providing products and services that always exceed their expectations. .
Continuous Improvement – We stay ahead of the competition by continually and relentlessly examining how we do business and determining new ways to move the business forward. This is everyone's primary responsibility to themselves, to their teammates and the company.
Results Culture – Our people thrive on achievement. It is a core trait of our people and organization. We take on challenges that make us better and are not satisfied until we accomplish our objective.
Stewardship – In order to fulfill our core purpose and achieve our vision we must be fanatical stewards of our resources (money, time, tools, equipment, materials, etc) for the betterment of the company and our customers. Good Stewardship is the key to the long-term viability of the company.
